Contact information
Type
Scientific
Primary contact
Dr Eugenia Oviedo-Joekes
ORCID ID
Contact details
School of Population and Public Health
University of British Columbia
Centre for Health Evaluation & Outcome Sciences
St. Paul's Hospital
620-1081 Burrard Street
Vancouver
BC
V6Z 1Y6
Canada
+1 604 682 2344 Ext 62973
eugenia@mail.cheos.ubc.ca
Additional identifiers
EudraCT number
2005-002896-33
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Efficacy of prescribed injected diacetylmorphine in the Andalusian trial: responders and non-responders evaluated using a multi-domain outcome index
Acronym
PEPSA
Study hypothesis
The impact of intravenous diacetylmorphine (DAM) plus oral methadone is better than a treatment with oral methadone alone on the physical and mental health and social integration of refractory opioid addicts.
Ethics approval
Ethics board of the Hospital Virgen de las Nieves, approved on 01/08/2001 (ref: 01/15.2)
Study design
Open randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Refractory opioid addicts
Intervention
Participants in the experimental group received DAM (heroin) injection twice a day, plus oral methadone once a day (to be taken at home) for 9 months. The control group received only oral methadone to be taken once a day.
Dosage:
The two groups received an equivalent opioid dose. Among treatment completers, an average DAM dosage of 274.5 mg/day (range: 15-600 mg) and an average methadone dosage of 42.6 mg/day (range 18-124 mg) were prescribed for the experimental group. The daily methadone dosage in the control group was 105 mg/day (range: 40-180 mg).
As a result, the approximate mean daily total equivalent dosage of DAM/day for the experimental group was between 395.5 and 414.5 mg/day; for the control group, it was between 361 and 400 mg/day.
Of the 62 participants, 44 completed the treatment and 50 patients were analysed.
Contact details of Principal Investigator:
Dr Joan Carles March
Andalusian School of Public Health (EASP)
Granada
18014, Spain
Tel: +34 958 027 400
Email: emilio.pereamilla@gmail.com
Intervention type
Drug
Phase
Not Applicable
Drug names
Diacetylmorphine (DAM; heroin), methadone
Primary outcome measures
A dichotomous multidimension outcome (MDO) index was determined by protocol as a primary outcome variable, imputing success when the patient showed at least 20% improvement at 9 months, compared with the baseline values, in general health or psychological or family adjustment, without a deterioration superior to 20% in any of these dimensions evaluated with the respective Addiction Severity Index (ASI) composite scores.
Secondary outcome measures
The following were assessed before randomisation, at 3, 6 and 9 months (end of the trial):
1. Physical and mental health, assessed by the Opiate Treatment Index (OTI), Symptom Checklist (SCL) and Maudsley Addiction Profile (MAP)
2. Psychosocial adjustment, assessed by the OTI and ASI
3. Treatment retention
4. Illegal activities, assessed by the ASI
5. Illicit drug use, assessed by the OTI and ASI
6. Quality of life, assessed by the Health Related Quality of Life 12-item Short Form (SF-12)
Overall trial start date
15/02/2003
Overall trial end date
15/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Both males and females, 21 years or older
2. Long-term opioid-dependent persons who had not been benefited from other treatments
Potential participants were interviewed in squares, soup kitchens and methadone dispensaries by outreach workers and peers, who suggested they make an appointment with a PEPSA physician.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
62
Participant exclusion criteria
1. Non-agreement to participate
2. Psycho-social impairment to answer the questionnaires
3. Current medical, social or legal situation that is likely to result in an discontinuation period longer than the study period (9 months)
Recruitment start date
15/02/2003
Recruitment end date
15/12/2004
Locations
Countries of recruitment
Spain
Trial participating centre
School of Population and Public Health
Vancouver, BC
V6Z 1Y6
Canada
Sponsor information
Organisation
Drug Commission, Council for Equality and Social Welfare (Spain)
Sponsor details
C/o Andrés Estrada Moreno
Director General para las Drogodependencias y Adicciones
Consejería para la Igualdad y Bienestar Social
Junta de Andalucia
Avenida de Hytasa
14
Sevilla
41071
Spain
+34 955 048 000
DGDrogodependenciasyAdicciones.cibs@juntadeandalucia.es
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Committee on Drug Dependence, Carlos III Health Institute (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2004 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15228924
2. 2006 main results: http://www.ncbi.nlm.nih.gov/pubmed/16919749
3. 2007 review including data from this trial in http://www.ncbi.nlm.nih.gov/pubmed/17562183
4. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18299779
5. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19682360
2008 results, comparing the baseline data from Canadian sample with the European trials, including the data from this trial: http://www.ncbi.nlm.nih.gov/pubmed/18758964
Publication citations
-
Results
Perea-Milla E, Ayçaguer LC, Cerdà JC, Saiz FG, Rivas-Ruiz F, Danet A, Vallecillo MR, Oviedo-Joekes E, Efficacy of prescribed injectable diacetylmorphine in the Andalusian trial: Bayesian analysis of responders and non-responders according to a multi domain outcome index., Trials, 2009, 10, 70, doi: 10.1186/1745-6215-10-70.
-
March JC, Oviedo-Joekes E, Romero M, Gómez M, Rodríguez S, León MI, Rodríguez C, , [The experimental drug prescription program in Andalusia [PEPSA]: procedure for recruiting participants]., Gac Sanit, 18, 3, 245-247.
-
March JC, Oviedo-Joekes E, Perea-Milla E, Carrasco F, , Controlled trial of prescribed heroin in the treatment of opioid addiction., J Subst Abuse Treat, 2006, 31, 2, 203-211, doi: 10.1016/j.jsat.2006.04.007.
-
Fischer B, Oviedo-Joekes E, Blanken P, Haasen C, Rehm J, Schechter MT, Strang J, van den Brink W, Heroin-assisted treatment (HAT) a decade later: a brief update on science and politics., J Urban Health, 2007, 84, 4, 552-562, doi: 10.1007/s11524-007-9198-y.
-
de Arcos FA, Verdejo García A, López Jiménez A, Montañez Pareja M, Gómez Juárez E, Arráez Sánchez F, Pérez García M, [Emotional response to affective stimuli in subjects addicted to opiates engaged in controlled use as part of the P.E.P.S.A]., Adicciones, 2008, 20, 1, 27-35.
-
Oviedo-Joekes E, Nosyk B, Brissette S, Chettiar J, Schneeberger P, Marsh DC, Krausz M, Anis A, Schechter MT, The North American Opiate Medication Initiative (NAOMI): profile of participants in North America's first trial of heroin-assisted treatment., J Urban Health, 2008, 85, 6, 812-825, doi: 10.1007/s11524-008-9312-9.